Stryker Orthopaedics
Medical device manufacturer in Mahwah Montclair, NJ.
24510(k) clearances
0PMA approvals
6recalls
Device types
- LPH Prosthesis, Hip, Semi-Constrained… 6
- MBH Prosthesis, Knee, Patello/Femorotibial… 5
- LZO Prosthesis, Hip, Semi-Constrained… 4
- MEH Prosthesis, Hip, Semi-Constrained… 2
- JWH Prosthesis, Knee, Patellofemorotibial… 2
- HSD Prosthesis, Shoulder, Hemi-, Humeral… 1
- LOD Bone Cement 1
- HRS Plate, Fixation, Bone 1
- JDG Prosthesis, Hip, Femoral Component… 1
- JDI Prosthesis, Hip, Semi-Constrained… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K211703 | Insignia Hip StemMEH · Traditional | 08/16/2021SE |
| K191414 | EXETER Centralizer, EXETER 2.5mm PlugJDI · Traditional | 08/28/2019SE |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsJDG · Traditional | 03/19/2018SE |
| K173849 | Triathlon Total Knee SystemMBH · Traditional | 02/02/2018SE |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemJWH · Traditional | 10/30/2017SE |
| K153345 | Stryker Orthopaedics Hip Systems Labeling UpdateLPH · Traditional | 05/25/2016SE |
| K151264 | Restoration Anatomic ShellLPH · Traditional | 08/10/2015SE |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…LPH · Traditional | 02/09/2015SE |
| K143393 | Triathlon Tritanium Cone AugmentsMBH · Traditional | 01/13/2015SE |
| K142462 | Restoration Anatomic ShellLPH · Traditional | 11/14/2014SE |
| K141056 | Triathlon Knee System Posterior Stabilized ComponentsMBH · Traditional | 08/05/2014SE |
| K132624 | Triathlon Tritanium Metal-Backed PatellaMBH · Traditional | 11/26/2013SE |
| K072575 | Triathlon Screw-Fixation Tibial BaseplateMBH · Traditional | 01/07/2008SE |
| K070170 | Dall-Miles SystemHRS · Traditional | 03/02/2007SE |
| K063816 | Pca Alumina Femoral HeadsLZO · Traditional | 02/02/2007SE |
| K063822 | Modification to Hipstar Femoral StemLPH · Special | 01/25/2007SE |
| K062553 | Simplex P Bone CementLOD · Traditional | 01/08/2007SE |
| K051223 | Hipstar Femoral StemLZO · Traditional | 05/10/2006SE |
| K053514 | Triathlon Total Knee SystemJWH · Traditional | 01/26/2006SE |
| K053528 | Short Citation Femoral StemMEH · Special | 01/13/2006SE |
| K052542 | Accolade RPS Hip StemLZO · Special | 09/27/2005SE |
| K051741 | Accolade HFX Femoral StemLZO · Traditional | 09/26/2005SE |
| K040432 | Solar 2 Anatomic ShoulderHSD · Traditional | 01/07/2005SE |
| K040412 | Trident T Acetabular ShellsLPH · Traditional | 05/25/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1915-2024 Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee…Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number… | 04/15/2024Open, Classified |
| Z-1914-2024 Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee…Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number… | 04/15/2024Open, Classified |
| Z-1913-2024 Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee…Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number… | 04/15/2024Open, Classified |
| Z-1912-2024 Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee…Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number… | 04/15/2024Open, Classified |
| Z-1911-2024 Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee…Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number… | 04/15/2024Open, Classified |
| Z-1910-2024 Class II | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee…Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number… | 04/15/2024Open, Classified |